Coverage of clinical trial service

Official inquiry from the MFDS

Official inquiry to confirm medical device applicability, class and classification

confirmation of the need for a clinical trial

Selection of institution and researcher

Institution selection and relevance review

researcher selection and relevance review

Preparation of a research plan

CRO quotation

Plan for study budget

protocol review

budget review and negotiation

MFDS / IRB communication

MFDS visit consultation, IDE application

IRB application for review

A contract conclusion

contract review and consignment of contract work

preparation of victim compensation rules and taking out insurance

Clinical trial operation

Investigational device management

project management

monitoring and document management

End of clinical trial

IRB end of trial report

Report of clinical study results

in connection with DM, a statistical analysis team